[no_toc] Legislations And Regulations of Organic Pigment
Legislation and regulations for pigments are primarily related to food packaging, consumer goods, and toys. Two general principles must be satisfied;
1. The pigment producer has to assure his customer that the pigment is toxicological of no concern.
2. The manufacturer of the pigmented articles must guarantee that the pigment neither migrates into food nor migrates from consumer goods or toys.
Main Legislation Concerning Organic Pigments
Materials and articles intended to come into contact with foodstuff are generally regulated in the EU in the Framework Directive 89/109/EEC. Under this Directive Single Directives are released, such as for Plastic Material (90/128/EEC), Cellulose Films (83/229/EEC), Elastomers and Rubber (93/11/EEC) and others. Directive 89/109/EEC generally requires that the constituents of all food contact material do not transfer to food stuff in quantities which could endanger human health.
European Union AP (89) 1 (1989)
Council of Europe Resolution AP (89) 1 (1989)
- The maximum threshold limits of metals or metal ions soluble in 0,1 m hydrochloric acid is as follows: Metal ppm Metal ppm As 100 Hg 50 Ba 100 Pb 100 Cd 100 Sb 500 Cr 1000 Se 100
- The trace amount of primary aromatic amines, which are soluble in 1 m hydrochloric acid, must be lower than 500 ppm (expressed as aniline). ETAD*) developed a testing method for aromatic amines .
- The threshold limit for aromatic amino sulfonic acids, expressed as aniline sulfonic acid, must be below 500 ppm.
- For benzidine, 2-naphthylamine and 4-aminodiphenyl the threshold limit is 10 ppm.
- The trace amount of polychlorinated biphenyls (PCB) should not exceed 25 mg/kg
The concentration limits of lead, Cadmium, Mercury, and Chromium (VI) in packaging material or components of packaging material are not allowed to exceed 100 ppm (cumulative). This is in force since June 30, 1994.
The Scientific Committee for Food (SCF) lays down for toxicological evaluation of food contact substances three levels of toxicological tests dependent on the amount of migration (mg/kg food simulant): Level 1: < 0.05; level 2: 0.05-5; level 3: >5
USA CONEG Regulation
nearly same as in 94/62/EEC (see above)
Several countries have released identical or similar regulations as the European Regulation AP (89)1 regarding the threshold limits for metals, aromatic amines, aromatic amino sulfonic acids and PCB.
On a national basis, Toys require compliance of limits for the same impurities as outlined under food packaging. In particular trace metal amounts have to be considered as well as threshold limits for aromatic amines, soluble in 0,07 m hydrochloric acid. The trace amount of cancerogenic amine should depend on the various countries, not exceed 5 or 10 ppm.
European Union EN 71-3 (1994)
European Toy-Norm EN 71-3 (1994), with different threshold limit levels
comply with FDA paragraphs 21 CFR 178, 3297 and apply for FCN(Food Contact Notifications)
Other Regulations Related
REACH & SHVC List
All halogen element shall below 50ppm
- Cl＜900ppm, Br＜900ppm
- Cl+Br ＜1500
Restriction of Certain Hazardous Substances (ROHS)
Aim: Electrical and electronic products bearing the CE mark shall meet ROHS 2.0 directive which effective since Jul.21st.2001
Cr VI ＜1000ppm
Automotive Materials EU 2000/53/EC Directive
EU 2000/53/EC Directive
From 2003 Jun 1st, Automotive materials shall without Pb, hg，Cr(VI), Cd except for listed exceptions.
Other Substances Related
Strict legal limits have been defined in some countries (for instance in the USA, and also throughout the European Union) because of the persistence and the wide distribution of these compounds. These regulations have primarily been issued in order to protect the environment, less because of a direct hazard for humans. Legislation 592 PCB traces may be found in two groups of organic pigments, namely in – azo pigments derived from chloroaniline or dichloro or tetrachlorodiamino- diphenyl, which may undergo various side reactions that produce traces of PCB, – pigments which are manufactured in the presence of dichlorobenzene or trichlorobenzene as a solvent. In this case, PCB may be formed through radical reactions.
Polychlorinated Dioxins/Furans (“Dioxins”)
Similar conditions as for the formation of PCB’s might also lead to the formation of small trace amounts of dioxins. A German Hazardous Substances Ordinance (Chemikalien-Verbotsverordnung) prohibits to place products on the market for which very low limits of dioxin traces are exceeded. Regulated dioxins are those which at least are tetrachloro (or bromo) substituted in 2,3,7,8-position Phthalates